Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H9/00—Pneumatic or hydraulic massage
  • A61H9/005—Pneumatic massage
  • A61H9/0078—Pneumatic massage with intermittent or alternately inflated bladders or cuffs
• • A—HUMAN NECESSITIES
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  • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
  • A61B17/132—Tourniquets
  • A61B17/1322—Tourniquets comprising a flexible encircling member
  • A61B17/1327—Tensioning clamps
• • A—HUMAN NECESSITIES
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  • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
  • A61B17/132—Tourniquets
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
  • A61B17/132—Tourniquets
  • A61B17/135—Tourniquets inflatable
• • H—ELECTRICITY
  • H01—ELECTRIC ELEMENTS
  • H01Q—ANTENNAS, i.e. RADIO AERIALS
  • H01Q1/00—Details of, or arrangements associated with, antennas
  • H01Q1/12—Supports; Mounting means
  • H01Q1/125—Means for positioning
• • H—ELECTRICITY
  • H04—ELECTRIC COMMUNICATION TECHNIQUE
  • H04B—TRANSMISSION
  • H04B7/00—Radio transmission systems, i.e. using radiation field
• • H—ELECTRICITY
  • H04—ELECTRIC COMMUNICATION TECHNIQUE
  • H04H—BROADCAST COMMUNICATION
  • H04H60/00—Arrangements for broadcast applications with a direct linking to broadcast information or broadcast space-time; Broadcast-related systems
  • H04H60/35—Arrangements for identifying or recognising characteristics with a direct linkage to broadcast information or to broadcast space-time, e.g. for identifying broadcast stations or for identifying users
  • H04H60/38—Arrangements for identifying or recognising characteristics with a direct linkage to broadcast information or to broadcast space-time, e.g. for identifying broadcast stations or for identifying users for identifying broadcast time or space
  • H04H60/41—Arrangements for identifying or recognising characteristics with a direct linkage to broadcast information or to broadcast space-time, e.g. for identifying broadcast stations or for identifying users for identifying broadcast time or space for identifying broadcast space, i.e. broadcast channels, broadcast stations or broadcast areas
• • H—ELECTRICITY
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  • H04H60/00—Arrangements for broadcast applications with a direct linking to broadcast information or broadcast space-time; Broadcast-related systems
  • H04H60/35—Arrangements for identifying or recognising characteristics with a direct linkage to broadcast information or to broadcast space-time, e.g. for identifying broadcast stations or for identifying users
  • H04H60/49—Arrangements for identifying or recognising characteristics with a direct linkage to broadcast information or to broadcast space-time, e.g. for identifying broadcast stations or for identifying users for identifying locations
  • H04H60/51—Arrangements for identifying or recognising characteristics with a direct linkage to broadcast information or to broadcast space-time, e.g. for identifying broadcast stations or for identifying users for identifying locations of receiving stations
• • H—ELECTRICITY
  • H04—ELECTRIC COMMUNICATION TECHNIQUE
  • H04N—PICTORIAL COMMUNICATION, e.g. TELEVISION
  • H04N21/00—Selective content distribution, e.g. interactive television or video on demand [VOD]
  • H04N21/40—Client devices specifically adapted for the reception of or interaction with content, e.g. set-top-box [STB]; Operations thereof
  • H04N21/43—Processing of content or additional data, e.g. demultiplexing additional data from a digital video stream; Elementary client operations, e.g. monitoring of home network or synchronising decoder's clock; Client middleware
  • H04N21/438—Interfacing the downstream path of the transmission network originating from a server, e.g. retrieving encoded video stream packets from an IP network
• • H—ELECTRICITY
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  • H04N—PICTORIAL COMMUNICATION, e.g. TELEVISION
  • H04N21/00—Selective content distribution, e.g. interactive television or video on demand [VOD]
  • H04N21/40—Client devices specifically adapted for the reception of or interaction with content, e.g. set-top-box [STB]; Operations thereof
  • H04N21/45—Management operations performed by the client for facilitating the reception of or the interaction with the content or administrating data related to the end-user or to the client device itself, e.g. learning user preferences for recommending movies, resolving scheduling conflicts
  • H04N21/4508—Management of client data or end-user data
  • H04N21/4524—Management of client data or end-user data involving the geographical location of the client
• • H—ELECTRICITY
  • H04—ELECTRIC COMMUNICATION TECHNIQUE
  • H04N—PICTORIAL COMMUNICATION, e.g. TELEVISION
  • H04N21/00—Selective content distribution, e.g. interactive television or video on demand [VOD]
  • H04N21/60—Network structure or processes for video distribution between server and client or between remote clients; Control signalling between clients, server and network components; Transmission of management data between server and client, e.g. sending from server to client commands for recording incoming content stream; Communication details between server and client 
  • H04N21/61—Network physical structure; Signal processing
  • H04N21/6106—Network physical structure; Signal processing specially adapted to the downstream path of the transmission network
  • H04N21/6143—Network physical structure; Signal processing specially adapted to the downstream path of the transmission network involving transmission via a satellite
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B2017/00743—Type of operation; Specification of treatment sites
  • A61B2017/00818—Treatment of the gastro-intestinal system
  • A61B2017/00827—Treatment of gastro-esophageal reflux
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/06—Measuring instruments not otherwise provided for
  • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
  • A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
  • A61H2201/12—Driving means
  • A61H2201/1238—Driving means with hydraulic or pneumatic drive
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
  • A61H2201/12—Driving means
  • A61H2201/1253—Driving means driven by a human being, e.g. hand driven
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
  • A61H2201/16—Physical interface with patient
  • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
  • A61H2201/165—Wearable interfaces
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
  • A61H2201/50—Control means thereof
  • A61H2201/5058—Sensors or detectors
  • A61H2201/5071—Pressure sensors
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H2205/00—Devices for specific parts of the body
  • A61H2205/04—Devices for specific parts of the body neck
• • H—ELECTRICITY
  • H04—ELECTRIC COMMUNICATION TECHNIQUE
  • H04H—BROADCAST COMMUNICATION
  • H04H60/00—Arrangements for broadcast applications with a direct linking to broadcast information or broadcast space-time; Broadcast-related systems
  • H04H60/09—Arrangements for device control with a direct linkage to broadcast information or to broadcast space-time; Arrangements for control of broadcast-related services
  • H04H60/14—Arrangements for conditional access to broadcast information or to broadcast-related services
• • H—ELECTRICITY
  • H04—ELECTRIC COMMUNICATION TECHNIQUE
  • H04N—PICTORIAL COMMUNICATION, e.g. TELEVISION
  • H04N5/00—Details of television systems
  • H04N5/44—Receiver circuitry for the reception of television signals according to analogue transmission standards
  • H04N5/50—Tuning indicators; Automatic tuning control

Definitions

• This invention relates to a device and method for exercising the swallowing muscles.
• Swallowing is a complicated multi-stage process that involves coordinated contraction of muscles in the tongue, lips and mouth, pharynx and esophagus, throat and neck. Swallowing can be divided into three functional stages - oral, pharyngeal, and esophageal.
• the pharyngeal phase or transfer phase, requires the hyoid bone and larynx to move superior and anterior, which brings the larynx out of the path of the bolus.
• Several muscle groups are activated during the pharyngeal phase. Muscles of the tongue are used to seal the oral cavity, while the digastric muscle, geniohyoid, and mylohyoid of the suprahyoid muscle group work to elevate the hyoid.
• the thyrohyoid muscle of the infrahyoid muscle group moves the thyroid cartilage to the base of the hyoid, consequently elevating the larynx and the upper esophageal sphincter, which is attached to the larynx, by 2 to 2.5 centimeters.
• Anterior movement of the larynx is a factor in the opening of the upper esophageal sphincter. Contraction of the longitudinal muscle group (palatopharyngeus, stylopharyngeus, salpingopharyngeus) elevates and shortens the pharynx. The action of the stylopharyngeus also widens the pharynx and opposes anterior movement of the posterior pharynx. The actions of these muscles elevate the larynx as well.
• Muscles in the pharyngeal constrictor group (superior pharyngeal constrictor muscle, middle pharyngeal constrictor muscle, inferior pharyngeal constrictor muscle) form a muscular "tunnel" and drive food into the esophagus through the already open upper esophageal sphincter, and this action is completed by pharyngeal peristaltic contraction.
• Dysphagia Damage to or weakness in the muscles and motor control of various structures can result in difficulty in swallowing, i.e., "dysphagia”.
• Dysphagia can also be the result of damage to sensory nerves or sensory processing from the periphery to the cortex, which can be manifest as a reduced awareness of oral or pharyngeal light "touch " and a delay in triggering the pharyngeal swallow. Swallow apraxia, or difficulty in programming motor actions during swallow, can also have a sensory component.
• Dysphagia may occur following stroke and traumatic brain injury, aging and after debilitating illness such as Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, and head, neck and esophageal cancer.
• U.S. Patent No. 8,388,561 describes a device for treating a subject with dysphagia or a speech disorder.
• the device includes a band equipped with a vibrator that is wrapped around the neck and positioned over the larynx. Upon activation the vibrator vibrates the larynx.
• the device contains an automatic stimulation controller that cycles on and off to initiate and maintain vibro-tactile stimulation to induce swallowing.
• the device also includes a movement and or related physiological sensor for monitoring pressure or movement changes due to elevation of the subject's larynx during attempts to swallow. In this system, the patient "cues" the system immediately before he/she swallows. The system displays this cue along with the subsequent changes in pressure etc.
• the device utilizes vibratory stimulation to induce swallowing, a sensation that may be uncomfortable for patients using the device. Additionally, the vibro-tactile stimulation is used to trigger swallowing, an action not correlated with natural bodily function.
• the present invention provides a swallow exerciser device for improving swallowing function in a subject (e.g., a mammal).
• the device includes a rigid outer shell, an adjustable fastener, and an inflatable conforming inner pad.
• the rigid shell has a longitudinal dimension such that the shell extends above a larynx of the subject and extends below the larynx of the subject when the swallow exerciser device is positioned over the larynx of the subject.
• the shell has a distal surface and a proximal surface.
• the adjustable fastener is dimensioned to secure the shell around a neck of the subject with the shell positioned over the larynx of the subject.
• the inflatable pad is connected to the proximal surface of the shell.
• the inflatable pad is dimensioned to apply resistance to force of at least one swallowing muscle of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in an inflated position.
• the adjustable fastener is connected to the shell.
• a spacer e.g., a bar
• the spacer is attached to the shell and/or the adjustable fastener.
• the spacer is inwardly spaced from a perimeter edge of the shell.
• the inflatable pad can be dimensioned to apply resistance to force of at least one muscle of the tongue of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad can be dimensioned to apply resistance to force of at least one suprahyoid muscle of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad can be dimensioned to apply resistance to force of at least one of the digastric muscle, geniohyoid, and mylohyoid of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad can be dimensioned to apply resistance to force of at least one infrahyoid muscle of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad can be dimensioned to apply resistance to force of at least one muscle of a longitudinal muscle group of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad can be dimensioned to apply resistance to force of at least one of the palatopharyngeus, stylopharyngeus and salpingopharyngeus of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad can be dimensioned to apply resistance to force of at least one pharyngeal constrictor muscle of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad can be dimensioned to increase resistance to a flow of swallowed food out of a pharynx of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad can be dimensioned to apply resistance to superior and anterior movement of the larynx of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad can be dimensioned to apply resistance to superior movement of a hyoid bone of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad can be dimensioned to avoid applying pressure to a carotid artery of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad can be dimensioned to avoid applying pressure to a jugular vein of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• a transverse cross-section of the proximal surface of the shell is concave.
• a transverse cross- section of the proximal surface of the shell taken along a transverse axis of the shell is concave along an entire length of the transverse cross-section.
• a longitudinal cross-section of the proximal surface of the shell is concave.
• a longitudinal cross-section of the proximal surface of the shell taken along a longitudinal axis of the shell is concave along an entire length of the longitudinal cross-section.
• a transverse cross-section of the proximal surface of the shell is concave
• a longitudinal cross-section of the proximal surface of the shell is concave
• the longitudinal cross-section of the proximal surface is less concave than the transverse cross-section of the proximal surface
• the shell is dimensioned to secure the shell around the neck of the subject such that the shell extends from cricoid cartilage to thyroid cartilage of the subject along a longitudinal axis of the shell.
• the shell is dimensioned to secure the shell around the neck of the subject such that the shell extends from cricoid cartilage to above a hyoid bone of the subject along a longitudinal axis of the shell.
• the proximal surface of the shell includes an indentation for receiving the inflatable pad.
• a viscoelastic layer is attached to a proximal side of the inflatable pad.
• the viscoelastic layer may comprise a shape memory foam.
• a proximal layer covers a proximal side of the viscoelastic layer.
• the proximal layer can comprise a fabric.
• the device does not trigger swallowing in the subject.
• the device does not include a vibrating element.
• the device does not include an electrical element.
• the adjustable fastener includes a hook-type fastener component and a loop-type fastener component.
• the device includes an inflation apparatus for inflating and deflating the inflatable pad, wherein the inflation apparatus includes a pump for inflating the inflatable pad, a conduit in fluid communication with the inflatable pad and the pump, and a valve for regulating inflation and deflation of the inflatable pad.
• the inflation apparatus may further comprise a gage for measuring a pressure level in the inflatable pad.
• the present invention provides a method for improving swallowing function in a subject.
• the method comprises positioning a swallow exerciser device over the larynx of the subject.
• the swallow exerciser device includes (i) a shell having a longitudinal dimension such that the shell extends above a larynx of the subject and extends below the larynx of the subject wherein the shell has a distal surface and a proximal surface, (ii) an adjustable fastener that is dimensioned to secure the shell around a neck of the subject with the shell positioned over the larynx of the subject, and (iii) an inflatable conforming pad connected to the proximal surface of the shell wherein the inflatable pad is
• the subject swallows after positioning the device over the larynx of the subject.
• the swallow exerciser device exercises the swallowing muscles and thereby strengthens the muscles involved in swallowing by making them "work harder”.
• the adjustable fastener of the swallow exerciser device is connected to the shell.
• a spacer e.g., a bar
• the spacer is attached to the shell and/or the
• the spacer of the swallow exerciser device is inwardly spaced from a perimeter edge of the shell.
• the inflatable pad when the inflatable pad is in the inflated position, the inflatable pad exerts pressure between the shell and the neck of the subject in a pressure range of 10 to 50 mm Hg. In another version of the method, when the inflatable pad is in the inflated position, the inflatable pad exerts pressure between the shell and the neck of the subject in a pressure range of 10 to 40 mm Hg. In another version of the method, when the inflatable pad is in the inflated position, the inflatable pad exerts pressure between the shell and the neck of the subject in a pressure range of 10 to 30 mm Hg.
• the method may further comprise increasing a pressure in the inflatable pad after the subject swallows at least one time.
• the method may further comprise removing the device after the subject swallows at least one time with a first pressure in the inflatable pad, and positioning the swallow exerciser device over the larynx of the subject a second time with a second pressure in the inflatable pad, wherein the second pressure is greater than the first pressure.
• the method may further comprise removing the device after the subject swallows at least one time with the second pressure in the inflatable pad, and positioning the swallow exerciser device over the larynx of the subject a third time with a third pressure in the inflatable pad, wherein the third pressure is greater than the second pressure.
• the device is positioned such that the shell extends about 1 to 2 centimeters above the larynx and the shell extends about 1 to 2 centimeters below the larynx.
• the device is positioned such that the inflatable pad applies resistance to force of at least one muscle of the tongue of the subject when the inflatable pad is in the inflated position.
• the device is positioned such that the inflatable pad applies resistance to force of at least one suprahyoid muscle of the subject when the inflatable pad is in the inflated position.
• the device is positioned such that the inflatable pad applies resistance to force of at least one infrahyoid muscle of the subject when the inflatable pad is in the inflated position.
• the device is positioned such that the inflatable pad applies resistance to force of at least one of the palatopharyngeus, stylopharyngeus and salpingopharyngeus of the subject when the inflatable pad is in the inflated position.
• the device is positioned such that the inflatable pad applies resistance to force of at least one pharyngeal constrictor muscle of the subject when the inflatable pad is in the inflated position.
• the method fatigues a pharynx of the subject. In another version of the method, the method fatigues a proximal striated esophagus of the subject. In another version of the method, the method fatigues both a pharynx and a proximal striated esophagus of the subject. In another version of the method, the method provides a resistive load to anterior and superior movement of a hyoid and a larynx of the subject.
• Figure 1 is a front view of a subject wearing a swallow exerciser device according to one embodiment of the invention.
• Figure 2 is a longitudinal cross-sectional view of the swallow exerciser device of Figure 1 taken along line 2-2 of Figure 1 .
• Figure 3 is a transverse cross-sectional view of the swallow exerciser device of Figure 1 taken along line 3-3 of Figure 1 .
• Figure 4 is a front view of a subject wearing a swallow exerciser device according to another embodiment of the invention.
• Figure 5 is a longitudinal cross-sectional view of the swallow exerciser device of Figure 4 taken along line 5-5 of Figure 4.
• Figure 6 is a transverse cross-sectional view of the swallow exerciser device of Figure 4 taken along line 6-6 of Figure 4.
• Figure 7 is a contour plot from the recording device of a high resolution manometry (HRM) system.
• HRM high resolution manometry
• the HRM recording device produces a color-contour plot, with time on the x-axis, esophageal length on the y-axis, and pressure represented by a color scale.
• the position of the pharynx, and the upper esophageal sphincter (UES) are depicted.
• Figure 8 is a contour plot from the recording device of a high resolution manometry (HRM) system showing how contractile integral (CI) can be measured using an HRM system.
• HRM high resolution manometry
• Figure 9 is a plot from the recording device of a high resolution manometry (HRM) system showing how nadir sensor can be identified using an HRM system.
• HRM high resolution manometry
• Figure 10 is a plot from the recording device of a high resolution manometry (HRM) system showing how nadir sensor contractile integral (CI) can be identified using an HRM system.
• HRM high resolution manometry
• Figure 1 1 shows an analysis of contractile integral (CI) slope.
• Figure 12 shows another analysis of contractile integral (CI) slope by age.
• Figure 13 shows another analysis of contractile integral (CI) slope by age.
• Figure 14 shows an analysis of contractile integral (CI) slope per swallow quartile.
• the bars reading left to right in each group of the graph are in the same order as the right hand legend reading top to bottom.
• Figure 15 shows another analysis of contractile integral (CI) slope per swallow quartile.
• the bars reading left to right in each group of the graph are in the same order as the right hand legend reading top to bottom.
• Figure 16 shows another analysis of contractile integral (CI) slope per swallow quartile.
• the bars reading left to right in each group of the graph are in the same order as the right hand legend reading top to bottom.
• Figure 17 shows graphs of the pharyngeal contractile integral (PhCI) with and without use of a swallow exerciser device of the present invention (referred to as a Resistance Exercise Device (RED) in Figure 17).
• PhCI pharyngeal contractile integral
• RED Resistance Exercise Device
• Figure 18 shows graphs of the effect of the swallow exerciser device of the invention (referred to as a Resistance Exercise Device (RED) in Figure 18) on pharyngeal peristalsis in sequential swallows.
• RED Resistance Exercise Device
• Figure 19 shows graphs of the effect of the swallow exerciser device of the invention (referred to as a Resistance Exercise Device (RED) in Figure 19) on pharyngeal peristalsis in sequential swallows.
• RED Resistance Exercise Device
• the pharyngeal peristaltic pressures have decreased compared to earlier swallows indicating the fatigue of the pharyngeal muscles which is necessary for the muscles to strengthen by exercise.
• Figure 20 shows graphs of the effect with and without use of a swallow exerciser device of the invention (referred to as a Resistance Exercise Device (RED) in Figure 20) on pharyngeal contraction in the proximal pharynx.
• a Resistance Exercise Device RED
• Figure 21 shows graphs of the effect with and without use of a swallow exerciser device of the invention (referred to as a Resistance Exercise Device (RED) in Figure 21 ) on pharyngeal contraction.
• a Resistance Exercise Device RED
• Figure 22 shows graphs of the effect with and without use of a swallow exerciser device of the invention (referred to as a Resistance Exercise Device (RED) in Figure 22) on the onset of fatigue.
• Figure 23 shows graphs of the effect of exerciser load of the swallow exerciser device of the invention on the pharyngeal contractile integral (PhCI) with and without use of the swallow exerciser device of the present disclosure.
• FIG. 1 to 3 there is shown a swallow exerciser device 10 according to one non-limiting embodiment of the invention positioned on the neck 13 of a human subject 21 .
• the human subject 21 has anatomical features shown including a larynx 12, a neck 13, a tongue 14, a pharynx 15, hyoid bone 16, cricoid cartilage 17, thyroid cartilage 18 (Adam's apple), and an esophagus 19.
• the swallow exerciser device 10 shown has a shell 23, an adjustable fastener 30, and an inflation apparatus 50 for inflating and deflating an inflatable pad 37.
• the shell 23 in the non-limiting embodiment shown has a generally oval perimeter edge 27.
• the shell 23 has a distal surface 24 and a proximal surface 25.
• the shell 23 may comprise a rigid polymeric material such as a polyolefin (e.g., polyethylene, polypropylene), a polyurethane, or a polycarbonate.
• the thickness of the shell 23 may be, for example, 1 to 5 millimeters.
• the shell 23 has an overall longitudinal dimension taken along its longitudinal axis L (see Fig. 1 ) such that the shell 23 extends above the larynx 12 of the subject 21 and extends below the larynx 12 of the subject 21 .
• the shell 23 has an overall longitudinal dimension taken along the longitudinal axis L such that the shell 23 extends from cricoid cartilage 17 to thyroid cartilage 18 of the subject 21 .
• the shell 23 has an overall longitudinal dimension taken along the longitudinal axis L such that the shell 23 extends from cricoid cartilage 17 to above a hyoid bone 16 of the subject 21 .
• the shell 23 has an overall longitudinal dimension taken along the longitudinal axis L of about 5 centimeters. In another embodiment, the shell 23 has an overall longitudinal dimension taken along the longitudinal axis L of about 4 centimeters. In another embodiment, the shell 23 has an overall longitudinal dimension taken along the longitudinal axis L of about 3 centimeters. In another embodiment, the shell 23 has a transverse dimension taken along the transverse axis T (see Fig. 1 ) of about 2 to about 5 centimeters.
• a longitudinal cross-sectional view of the swallow exerciser device 10 shows one non-limiting example positioning of the swallow exerciser device 10 with relation to several anatomical features.
• the longitudinally concave shell 23 extends from below the cricoid cartilage 17 to above the hyoid bone 16.
• an external pressure applied to the subject's neck via the swallow exerciser device 10 provides resistance to the larynx 12 and hyoid 16 being drawn superiorly and anteriorly by swallowing muscles.
• a longitudinal cross-section of the proximal surface 25 of the shell 23 taken along the longitudinal axis L of the shell 23 is concave.
• the longitudinal cross-section of the proximal surface 25 of the shell 23 taken along longitudinal axis L of the shell 23 is concave along an entire length of the longitudinal cross-section.
• a transverse cross-section of the proximal surface 25 of the shell 23 is concave.
• the transverse cross-section of the proximal surface 25 of the shell 23 taken along a transverse axis T (see Fig. 1 ) of the shell 23 is concave along an entire length of the transverse cross-section.
• the longitudinal cross-section of the proximal surface 25 is less concave than the transverse cross-section of the proximal surface 25.
• the adjustable fastener 30 of the exerciser device 10 comprises a first band 31 attached on one side of the perimeter edge 27 of the shell 23 and a second band 32 attached on an opposite side of the perimeter edge 27 of the shell 23.
• the first band 31 has a hook-type fastener component 34 at its distal end section
• the second band 32 has a loop-type fastener component 33 at its distal end section.
• the hook and loop fastener arrangement may be one sold under the trademark Velcro.
• the adjustable fastener 30 allows the shell to be secured around the neck 13 of the subject 21 as shown in Figures 1 and 2 via the hook and loop fastener arrangement.
• the inflatable pad 37 is secured to the shell 23 in an indentation 26 in the distal surface 24 of the shell 23.
• the inflation apparatus 50 includes a pump 51 , a conduit 52 which allows for fluid (e.g., air) flow between the pump 51 and the inflatable pad 37, and a valve 53 for regulating inflation and deflation of the pad 37. Additionally, a pressure gage 54 is used to measure a pressure level in the pad 37.
• the inflatable pad 37 is in fluid communication with a port 38 for releasably connecting the conduit 52 when inflating and deflating the inflatable pad 37.
• the port 38 may also include a valve for controlling the flow of air into the inflatable pad 37.
• the inflatable pad 37 can be inflated by squeezing the pump 51 which can be in the form of a bulb.
• the pressure produced by inflatable pad 37 can then be read using the gage 54.
• the gage 54 may be connected via a tube that is long enough for the subject to be able to read the gage 54.
• the bulb-type pump 51 may be replaced with means to automatically insert pressurized air into inflatable pad 37, such as an air pump.
• a viscoelastic layer 40 is attached to a proximal side of the inflatable pad 37.
• the viscoelastic layer may comprise a shape memory foam.
• the memory foam may be a viscoelastic open cell polyurethane foam which softens in reaction to body heat, allowing it to mold to a warm body in a few minutes.
• Some memory foam attributes include viscoelasticity which allows the foam to compress gradually, and memory, which means the foam returns to shape gradually.
• the thickness of the viscoelastic layer 40 may be, for example, 5 to 10 millimeters.
• the proximal layer 42 covers a proximal side of the viscoelastic layer 40.
• the proximal layer 42 comprises a fabric such as a washable, woven or knitted material.
• Example materials suitable for the fabric include synthetic fibers, natural fibers, and combinations thereof, further including cottons, poly/cottons, fleeces, wools, flannels, polyesters, nylons, etc.
• a preferred fabric is soft and comfortable.
• the inflatable pad 37 is dimensioned to apply resistance to force of at least one swallowing muscle of the subject when the shell 23 positioned over the larynx of the subject and when the inflatable pad is in an inflated position.
• the inflatable pad 37 may apply resistance to force of at least one muscle of the tongue of the subject.
• the inflatable pad 37 may apply resistance to force of at least one suprahyoid muscle of the subject.
• the inflatable pad 37 may apply resistance to force of at least one of the digastric muscle, geniohyoid, and mylohyoid of the subject.
• the inflatable pad 37 may apply resistance to force of at least one infrahyoid muscle of the subject.
• the inflatable pad 37 may apply resistance to force of at least one suprahyoid muscle of the subject.
• the inflatable pad 37 may apply resistance to force of at least one muscle of a longitudinal muscle group (e.g., palatopharyngeus, stylopharyngeus and salpingopharyngeus) of the subject.
• the inflatable pad 37 may apply resistance to force of at least one pharyngeal constrictor muscle (superior pharyngeal constrictor muscle, middle pharyngeal constrictor muscle, inferior pharyngeal constrictor muscle) of the subject.
• the inflatable pad 37 can be any suitable inflatable pad 37.
• the inflatable pad 37 can be
• the inflatable pad 37 can be dimensioned to apply resistance to superior and anterior movement of the larynx of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad 37 can be dimensioned to apply resistance to superior movement of a hyoid bone of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad 37 can be dimensioned to avoid applying pressure to a carotid artery of the subject when the shell positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad 37 can be dimensioned to avoid applying pressure to a jugular vein of the subject when the shell positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• a swallow exerciser device has been developed that exercises and thereby strengthens the muscles involved in swallowing by making them "work harder".
• the swallow exerciser device is 10-15 centimeters long and is placed around the neck covering the larynx extending 1 -2 centimeters above and below the larynx.
• the swallow exerciser device includes rigid plastic shell with an indentation on the proximal ("patient") side which accommodates the inflatable pad.
• the pad can be inflated to apply graded amounts (e.g., 10-30 mm Hg) of pressure, as determined with a hand-held pressure gage. When the subjects swallow, this pressure induces graded degrees of resistance as the muscles of swallowing contract.
• These muscles can be of groups such as: (a) internal muscles of the oral cavity (e.g. pharynx, tongue, palate, etc.), and (b) external muscles (suprahyoid and thyrohyoid).
• the swallow exerciser device also induces resistance to the flow of swallowed material out of pharynx and into the esophagus.
• the users participate in an exercise regimen. For example, 10 mm Hg is applied via the inflatable pad and the user swallows (or attempts to swallow, depending on his/her capabilities) thirty times at ten second intervals. This exercise set is repeated three times, three times per day for two weeks. The inflatable pad pressure is then increased to 20 mm Hg for the next two week cycle, and to 30 mm Hg for the following two week cycle and for future cycles. In another example, subjects will swallow repeatedly at a 30 second interval, morning, noon and in the evening for the lowest device pressure for a number of weeks (e.g., 2 weeks). Then the device pressure will be increased to the next level doing the same protocol for a number of weeks and so on.
• 10 mm Hg is applied via the inflatable pad and the user swallows (or attempts to swallow, depending on his/her capabilities) thirty times at ten second intervals. This exercise set is repeated three times, three times per day for two weeks.
• the inflatable pad pressure is then increased to 20 mm Hg for the next two week cycle, and to 30 mm
• a swallow exerciser device 1 10 positioned on the neck 13 of a human subject 21 .
• the human subject 21 has anatomical features shown including a larynx 12, a neck 13, a tongue 14, a pharynx 15, hyoid bone 16, cricoid cartilage 17, thyroid cartilage 18 (Adam's apple), and an esophagus 19.
• the swallow exerciser device 1 10 shown has a shell 123, an adjustable fastener 130, a spacer bar 144, and an inflation apparatus 50 for inflating and deflating an inflatable pad 137.
• the shell 123 in the non-limiting embodiment shown has a generally oval perimeter edge 127.
• the shell 123 has a distal surface 124 and a proximal surface 125.
• the shell 123 may comprise a rigid polymeric material such as a polyolefin (e.g., polyethylene, polypropylene), a polyurethane, or a polycarbonate.
• the thickness of the shell 123 may be, for example, 1 to 5 millimeters.
• the shell 123 has an overall longitudinal dimension taken along its longitudinal axis L (see Fig. 4) such that the shell 123 extends above the larynx 12 of the subject 21 and extends below the larynx 12 of the subject 21 .
• the shell 123 has an overall longitudinal dimension taken along the longitudinal axis L such that the shell 123 extends from cricoid cartilage 17 to thyroid cartilage 18 of the subject 21 .
• the shell 123 has an overall longitudinal dimension taken along the longitudinal axis L such that the shell 123 extends from cricoid cartilage 17 to above a hyoid bone 16 of the subject 21 .
• the shell 123 has an overall longitudinal dimension taken along the longitudinal axis L of about 5 centimeters. In another embodiment, the shell 123 has an overall longitudinal dimension taken along the longitudinal axis L of about 4 centimeters. In another embodiment, the shell 123 has an overall longitudinal dimension taken along the longitudinal axis L of about 3 centimeters. In another embodiment, the shell 123 has a transverse dimension taken along the transverse axis T (see Fig. 4) of about 2 to about 5 centimeters.
• a longitudinal cross-sectional view of the swallow exerciser device 1 10 shows one non-limiting example positioning of the swallow exerciser device 1 10 with relation to several anatomical features.
• the longitudinally concave shell 123 extends from below the cricoid cartilage 17 to above the hyoid bone 16.
• an external pressure applied to the subject's neck via the swallow exerciser device 1 10 provides resistance to the larynx 12 and hyoid 16 being drawn superiorly and anteriorly by swallowing muscles.
• a longitudinal cross-section of the proximal surface 125 of the shell 123 taken along the longitudinal axis L of the shell 123 is concave.
• the longitudinal cross-section of the proximal surface 125 of the shell 123 taken along longitudinal axis L of the shell 123 is concave along an entire length of the longitudinal cross-section.
• a transverse cross-section of the proximal surface 125 of the shell 123 is concave.
• the transverse cross-section of the proximal surface 125 of the shell 123 taken along a transverse axis T (see Fig. 4) of the shell 123 is concave along an entire length of the transverse cross-section.
• the longitudinal cross-section of the proximal surface 125 is less concave than the transverse cross-section of the proximal surface 125.
• the adjustable fastener 130 of the exerciser device 1 10 comprises a band 131 that has a hook-type fastener component 134 at its distal end section and a loop-type fastener component 133 at its distal end section.
• the hook and loop fastener arrangement may be one sold under the trademark
• the adjustable fastener 130 allows the shell to be secured around the neck 13 of the subject 21 as shown in Figures 4 and 5 via the hook and loop fastener arrangement.
• the spacer bar 144 is attached to the shell 123 and/or the band 131 , and is positioned between the shell 123 and the band 131 as shown in Figures 4-6.
• the spacer bar 144 has an overall longitudinal dimension taken along the longitudinal axis L (see Fig. 4) of about 3 to about 5 centimeters, a thickness of about 1 to about 2 centimeters, and a transverse dimension taken along the transverse axis T (see Fig. 4) of about 1 to about 2 centimeters.
• the spacer bar 144 is preferably spaced inward from the perimeter edge 127 of the shell 123.
• the spacer bar 144 serves to bridge the band 131 over the neck vital organs and prevent pressuring them.
• the spacer bar 144 serves to bridge the band 131 over a carotid artery of the subject and a jugular vein of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position such that the carotid artery and the jugular vein of the subject are not pressured.
• the inflatable pad 137 is secured to the shell 123 in an indentation 126 in the distal surface 124 of the shell 123.
• the inflation apparatus 50 includes a pump 51 , a conduit 52 which allows for fluid (e.g., air) flow between the pump 51 and the inflatable pad 137, and a valve 53 for regulating inflation and deflation of the pad 137. Additionally, a pressure gage 54 is used to measure a pressure level in the pad 137.
• the inflatable pad 137 is in fluid communication with a port 138 for releasably connecting the conduit 52 when inflating and deflating the inflatable pad 137.
• the port 138 may also include a valve for controlling the flow of air into the inflatable pad 137.
• the inflatable pad 137 can be inflated by squeezing the pump 51 which can be in the form of a bulb. The pressure produced by inflatable pad 137 can then be read using the gage 54.
• the gage 54 may be connected via a tube that is long enough for the subject to be able to read the gage 54.
• the bulb-type pump 51 may be replaced with means to automatically insert pressurized air into inflatable pad 137, such as an air pump.
• a viscoelastic layer 140 is attached to a proximal side of the inflatable pad 137.
• the viscoelastic layer may comprise a shape memory foam.
• the memory foam may be a viscoelastic open cell polyurethane foam which softens in reaction to body heat, allowing it to mold to a warm body in a few minutes.
• Some memory foam attributes include viscoelasticity which allows the foam to compress gradually, and memory, which means the foam returns to shape gradually.
• the thickness of the viscoelastic layer 140 may be, for example, 5 to 10 millimeters.
• the proximal layer 142 covers a proximal side of the viscoelastic layer 140.
• the proximal layer 142 comprises a fabric such as a washable, woven or knitted material.
• Example materials suitable for the fabric include synthetic fibers, natural fibers, and combinations thereof, further including cottons, poly/cottons, fleeces, wools, flannels, polyesters, nylons, etc.
• a preferred fabric is soft and comfortable.
• the inflatable pad 137 is dimensioned to apply resistance to force of at least one swallowing muscle of the subject when the shell 123 positioned over the larynx of the subject and when the inflatable pad is in an inflated position.
• the inflatable pad 137 may apply resistance to force of at least one muscle of the tongue of the subject.
• the inflatable pad 137 may apply resistance to force of at least one suprahyoid muscle of the subject.
• the inflatable pad 137 may apply resistance to force of at least one of the digastric muscle, geniohyoid, and mylohyoid of the subject.
• the inflatable pad 137 may apply resistance to force of at least one infrahyoid muscle of the subject.
• the inflatable pad 137 may apply resistance to force of at least one suprahyoid muscle of the subject.
• the inflatable pad 137 may apply resistance to force of at least one muscle of a longitudinal muscle group (e.g., palatopharyngeus, stylopharyngeus and salpingopharyngeus) of the subject.
• the inflatable pad 137 may apply resistance to force of at least one pharyngeal constrictor muscle (superior pharyngeal constrictor muscle, middle pharyngeal constrictor muscle, inferior pharyngeal constrictor muscle) of the subject.
• the inflatable pad 137 can be dimensioned to increase resistance to a flow of swallowed food out of a pharynx of the subject when the shell 123 is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad 137 can be
• the inflatable pad 137 can be dimensioned to apply resistance to superior and anterior movement of the larynx of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad 137 can be dimensioned to apply resistance to superior movement of a hyoid bone of the subject when the shell is positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the inflatable pad 137 can be dimensioned to avoid applying pressure to a carotid artery of the subject when the shell positioned over the larynx of the subject and when the inflatable pad is in the inflated position.
• the users participate in an exercise regimen such as that described above for the swallow exerciser device 10.
• a swallow exerciser device of the present disclosure was shown to be effective for inducing fatigue in pharyngeal peristalsis. Fatigue is important because based on exercise physiology principles, muscles strengthen when they are fatigued by exercise.
• Dysphagia treatment using exercise has ranged from isotonic- isometric head raising (Shaker R, Kern M, Bardan E, Taylor A, Stewart ET, Hoffmann RG, Arndorfer RC, Hofmann C, Bonnevier J., Am J Physiol. 1997 Jun;272(6 Pt
• the focus of the swallow exerciser device disclosed herein is to provide a resistive load to anterior and superior laryngeal movement thereby fatiguing muscle groups associated with deglutitive laryngeal movement. Effective and focused fatigue acts as a training mechanism for strengthening these muscle groups.
• Example 1 we refer to a swallow exerciser device of the present disclosure as a Resistance Exercise Device (RED).
• a resistance exercise device (RED) was manufactured in our lab to provide an adjustable and fixed resistance to anterior and superior movement of the hyo-laryngeal complex.
• the device comprised a cotton fabric strap 63.5 centimeters in length and 2 centimeters in width. The ends of the strap were affixed with VELCRO ® brand hook and loop fastening strips 21
• centimeters in length to customize fitting of the RED when the strap is wrapped around the neck.
• the middle portion of the device had an additional cotton pad 30 centimeters in length and 5 centimeters in width to provide support for the portion of the device that applies external force to the cricoid cartilage when positioned on the subject.
• a concave, flexible plastic disk was affixed to the middle of the strap assembly. This concave disk was wrapped in tape and serves as a support structure for an inflatable polyethylene bag which acts to apply an external force to the cricoid cartilage to restrict anterior and superior movement of the larynx.
• An inflatable bag was connected via a flexible catheter assembly to a hand pump and pressure gauge.
• the bag is maximally inflated on the bench and loosely wrapped with soft tape and subsequently deflated. In this way, the inflatable bag rests comfortably on the neck without skin irritation.
• the inflatable pad rests in a position on the cricoid fixed by closure of the VELCRO ® brand hook and loop fastening straps.
• a known external force may be applied to the cricoid by partially inflating the bag to a specific pressure reading on the gauge.
• the soft and compliant bag conforms to the surface of the skin cradling the irregular geometry of the cricoid while applying a resistive force to anterior and superior distraction of the hyo-laryngeal complex during swallowing.
• Pharyngeal and proximal esophageal pressure was monitored using a high resolution (HR) manometric catheter positioned transnasally to traverse the pharynx, upper esophageal sphincter (UES) and proximal esophagus.
• HR high resolution
• UES upper esophageal sphincter
• proximal esophagus The HR probe and computerized recording and analysis system (ManoScan and ManoView
• contractile integral technique has been utilized in the distal esophagus as metric of "contractile vigor" (see, Lin Z, Roman S, Pandolfino JE, Kahrilas PJ.,
• the contractile integral is calculated by scrolling out an area in the topographic display delineating a space-time box and logging the displayed contractile integral value.
• the PhCI was characterized by circumscribing a space- time box in the topographic ManoView display to surround the pharyngeal deglutitive pressure recording with the upper margin of the box at the most proximal probe sensor at a time prior to deglutition and the distal margin of the box at the
• Both the peak peristaltic pressures and the PhCI were used as manometric surrogates for detecting fatigue due to repeated deglutitive pharyngeal contraction against the increased load provided by the RED. These metrics were also evaluated for the swallow sequences without the RED. In a second order analysis, the linear regression slope and correlation coefficient of the peak pressures and PhCI across sequential swallows was evaluated wherein a significant negative correlation (or a negative slope statistically different than zero) was associated with fatigue of the deglutitive pharyngeal muscles.
• the pharyngeal contractile integrals showed slope differences between swallow tests with and without a swallow exerciser device of the present disclosure.
• Swallow against an increased external load induced by a swallow exerciser device of the present disclosure is effective for inducing fatigue in pharyngeal peristalsis.
• Example 2 reports a study on the effect of a swallow exerciser device of the present disclosure on the proximal esophagus. Data in Example 2 clearly shows fatigue of the proximal esophageal muscles by swallowing while wearing the swallow exerciser device. Fatigue is important because based on exercise physiology principles, muscles strengthen when they are fatigued by exercise.
• Example 2 sought to: (i) identify objective measurement parameters for proximal esophageal muscle; (ii) identify variability within measurement parameter methods, and (iii) observe any preliminary trends in the physiology and anatomy of proximal esophageal muscle response both with and without the swallow exerciser device.
• HRM high resolution manometry
• the patient was situated upright, and was fitted with the swallow exerciser device, which was set to 40 mmHg for the study, around the larynx. The patient was given 20 minutes to adjust to catheter and swallow exerciser device. The patient was prompted to conduct 40 wet swallows of 0.5 ml of water with the swallow exerciser device on. The swallow was prompted every 20 seconds. The swallow exerciser device pressure was reset to 0 mmHg and the patient was given a 10 minute rest period. The patient was prompted to conduct 40 wet swallows of 0.5 ml of water without the swallow exerciser device on. The swallow was prompted every 20 seconds. Upon study conclusion, the catheter and swallow exerciser device were removed. All analysis was conducted blindly in Manoview ESO 3.0 software.
• the demographics of the study were: 15 studies; 8 young ( ⁇ 40, 5 male / 3 female); 6 elderly (>65, 1 male / 5 female); 1 middle - age (41 - 64, male - male); all healthy; and 1 repeat (young).
• TZ Transition zone
• Figure 8 is a contour plot from the recording device of the HRM system showing how contractile integral (CI) was measured.
• the CI at 20 mmHg was taken using: (a) the initiation of swallow as left margin; (b) the right most portion of striated swallow as right margin; (c) the lower margin of the UES as the top margin; and (d) the specified length as the bottom margin.
• Figure 9 is a plot from the recording device of the HRM system showing how nadir sensor was identified
• Figure 10 is a plot from the recording device of the HRM system showing how nadir sensor contractile integral (CI) was identified.
• CI contractile integral
• Figure 1 1 shows an analysis of contractile integral (CI) slope.
• CI contractile integral
• Figures 14 to 16 show our analyses of contractile integral (CI) slope per swallow quartile.
• Each set of 40 swallows (both with and without the swallow exerciser device) was separated into 4 quartiles of 10 swallows each.
• the measured CI from the lower UES margin to 3 centimeters, 4 centimeters, and 5 centimeters below the lower UES margin, and to the nadir sensor, and CI was plotted per swallow for the designated quartile.
• the pharyngeal contractile integral can be used as a manometric surrogate for detecting fatigue due to the increased load provided by the swallow exerciser device of the present disclosure.
• the contractile integral shows statistically significant slope differences with a swallow exerciser device of the present disclosure, particularly in elderly subjects, suggesting fatigue. A potential pattern was exhibited in the CI quartile. Initial review of the parameters reveals relatively low inter-observer variability.
• swallow against an increased external load induced by a swallow exerciser device of the present disclosure is effective for inducing fatigue in the proximal esophagus.
• Example 3 reports a study on the effect of a swallow exerciser device of the present disclosure for swallowing on pharyngeal peristalsis. Data in Example 3 clearly shows fatigue of the pharyngeal muscles by swallowing while wearing the swallow exerciser device. The pharyngeal muscles can be strengthened when they are fatigued by exercise.
• the oral/pharyngeal phase of swallowing involves complex interactions between lingual, pharyngeal, oral, cervical and laryngeal muscles. In addition to precise coordination, adequate contractile function of these muscles are crucial for normal transport of the swallowed bolus out of the pharynx and into the esophagus.
• the elements involved in a normal oral/pharyngeal phase of swallowing include: (i) motor function (tongue and pharynx); (ii) relaxation/opening (UES, suprahyoid muscles); (iii) airway closure (larynx, velopharynx); (iv) sensory function; and (v) coordination and timing.
• Example 3 sought to determine the effect of increased swallow load induced by applying resistance to the anterior and superior excursions of the hyo-laryngeal complex on the parameters of the pharyngeal peristaltic pressure waves.
• a swallow exerciser device of the present disclosure that due to its configuration can induce graded resistance to the anterior and superior excursion of the hyo-laryngeal complex during swallowing.
• a swallow exerciser device of the present disclosure as a Resistance Exercise Device (RED).
• PhCI reflects the pressure phenomena across the entire pharynx
• further analysis revealed that the fatigue trend significantly affected some but not all of the recording sites.
• a one sample t-test was used to test to determine whether correlation coefficients are significantly different from zero with the listed probability of Type I error. See Table 1 below. TABLE 1
• Swallow against an increased external load induced by a swallow exerciser device of the present disclosure is safe and effective for inducing fatigue in pharyngeal peristalsis and thus can strengthen the pharyngeal constrictor muscles. This finding provides an opportunity for treatment of pharyngeal weakness observed in patients with oro-pharyngeal dysphagia.
• the invention provides a swallow exerciser device that exercises and thereby strengthens the muscles involved in swallowing.

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